Roche Cedex Bio Manuel utilisateur

Cedex Bio System

Operator’s Manual

Software Version 2.1

Cedex Bio System

Roche Diagnostics

2 Operator’s Manual · Version 3.1

Document information

Revision history

Edition notice The Cedex Bio instrument is a continuous random-access analyzer intended for the

determination of chemical and biochemical parameters in aqueous solutions. It is

optimized for small throughput workloads of approximately 20 samples per day,

utilizing photometric analysis and a unit for ion selective electrodes (ISE).

This manual is for users of the Cedex Bio instrument with software version 2.1.

Every effort has been made to ensure that all the information contained in this

manual is correct at the time of printing. However, Roche Diagnostics GmbH

reserves the right to make any changes necessary without notice as part of ongoing

product development.

Any customer modification to the instrument will render the warranty or service

agreement null and void.

Software updates are done by service representatives.

Intended use The Cedex Bio instrument is a continuous random-access analyzer intended for the

determination of chemical and biochemical parameters in aqueous solutions

For use in quality control/manufacturing process only.

It is important that the operators read this manual thoroughly before using the

system.

Trademarks The following trademarks are acknowledged:

CEDEX, COBAS, and ISE are trademarks of Roche.

All other trademarks are the property of their respective owners.

Contact address

Manual version Software version Revision date Changes

1.0 1.0 June 2011 First publication.

2.0 1.0 September 2011 Editorial corrections

3.0 2.0 July 2012 Hardware improvements.

Adjustments to reflect latest

software version (time indication

for running tests and disk space

indication).

3.1 2.1 November 2013 The TRL Check feature was

introduced. Minor textual

adjustments were made.

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Roche Diagnostics

Operator’s Manual · Version 3.1 3

Cedex Bio System

Table of contents

Document information 2

Contact address 2

Table of contents 3

Preface 5

How to use this manual 5

Online Help system 5

Conventions used in this manual 6

System Description Part A

1Safety

Safety classification A–5

Safety information A–5

Data security A–10

Disposal recommendation A–11

Legal liability A–12

Safety labels A–13

2 Introduction to the instrument

Overview A–17

User interface A–20

Wizards A–21

Daily operation A–22

Maintenance A–33

System status A–34

3 Hardware

Covers and panels A–39

LEDs A–41

Main components A–43

Hardware overview A–44

Technical specifications A–65

4 Software

Introduction A–69

Screen layout A–70

Display items A–71

Workflows and wizards A–72

Working with the user interface A–73

Key screens A–82

Color interpretation for LEDs A–117

Buttons A–119

Operation Part B

5 Daily operation

Introduction B–5

Starting the shift B–10

Preparing the system B–12

Analyzing samples B–34

Validating sample results B–51

Performing calibrations B–59

Performing QC B–68

Finishing the shift B–77

Logging off B–88

Shutting down the system and switching off

the instrument B–88

Using the barcode scanner B–89

6 Special operations

Deleting sample orders B–93

Deleting sample results B–94

Calibration B–95

Deleting QC results B–96

Lot handling B–98

Exporting data B–104

Importing data B–111

Preparing a new disk B–116

Assigning tests to test tabs B–119

Deleting bottle sets from the Inventory list B–120

Refilling printer paper B–122

Removing condensation water from the

reagent cooler B–124

Replacing the probe B–125

Connecting and disconnecting the external

fluid containers B–127

Adjusting the touchscreen B–131

Cleaning the touchscreen B–131

7 Configuration

Introduction B–135

Applications B–137

Configuration B–157

Maintenance Part C

8 General maintenance

Overview C–5

Maintenance actions C–8

Troubleshooting Part D

9 Messages and alarms

About messages D–5

Message screen D–5

Acoustic signals D–6

Alarm monitor D–6

List of alarm messages D–10

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4Operator’s Manual · Version 3.1

Cedex Bio System

10 Result flags

About flags D–25

Safety D–27

List of flags D–28

11 Troubleshooting

Introduction D–41

Dealing with exceptional situations D–42

Reacting to messages D–44

Detailed procedures D–46

ISE Part E

12 ISE description

Overview E–5

Hardware E–9

Basic operation E–12

Technical specifications E–13

13 ISE operation

Daily operation E–17

Replacing ISE fluid bottles E–30

Replacing electrodes E–32

Cleaning the ISE tower off the instrument E–36

14 ISE maintenance

Introduction E–41

ISE maintenance actions E–42

15 ISE troubleshooting

Introduction E–69

Safety E–70

List of ISE flags E–71

Reacting to error messages E–80

Glossary and Index Part F

Glossary F–3

Index F–11

Revisions Part G

18 Revisions

Roche Diagnostics

Operator’s Manual · Version 3.1 5

Cedex Bio System

Preface

The Cedex Bio Instrument is a continuous random-access analyzer intended for the

determination of chemical and biochemical parameters in aqueous solutions. It is

optimized for small throughput workloads of approximately 20 samples per day,

utilizing photometric analysis and a unit for ion selective electrodes (ISE).

This manual describes the Cedex Bio system features and general operational

concepts, and it provides operating, maintenance, and emergency procedures.

How to use this manual

To help you find information quickly, there is a table of contents at the beginning of

the manual and each chapter. In addition, a complete index can be found at the end.

Online Help system

The Cedex Bio instrument has a context-sensitive online Help feature to aid in its

operating. “Context-sensitive” means that wherever you are located within the

Cedex Bio software, choosing Help ( ) displays Help text relating to that area of

the software. The online Help offers a quick and convenient way of finding

information, such as explanations of screens and dialog boxes and on how to perform

particular tasks.

Parts B through D describe the instrument without using an ISE unit, ISE specific informa-

tion is given in part E.

oKeep this Operator’s Manual in a safe place to ensure that it is not damaged and

remains available for use.

oThis Operator’s Manual should be easily accessible at all times.

Cedex Bio System

Roche Diagnostics

6 Operator’s Manual · Version 3.1

Conventions used in this manual

Visual cues are used to help locate and interpret information in this manual quickly.

This section explains the formatting conventions used in this manual.

Symbols The following symbols are used:

Buttons When used for identification purposes, a generic form of the buttons is used, without

color or navigation indicators.

Screenshots The screen representations shown in this publication are for illustrative purposes

only. The screens do not necessarily show valid data.

Symbol Used for

aStart of procedure

oList item

Cross-reference

hCall-up (software navigation path)

Color of display item on the screen

Tip

Safety alert

Electrical and electronic equipment marked with this symbol are

covered by the European directive WEEE.

The symbol denotes that the equipment must not be disposed of in

the municipal waste system.

Roche Diagnostics

Operator’s Manual · Version 3.1 7

Cedex Bio System

Abbreviations The following abbreviations are used:

Abbreviation Definition

Cfas Calibrator for automated systems

DIL Diluent

DM Data management

DRAM Dynamic random access memory

e.g. Exempli gratia – for example

EMC Electromagnetic compatibility

EN European standard

i.e. Id est – that is to say

IEC International Electrical Commission

ISE Ion selective electrode

LED Light-emitting diode

LIS Laboratory information system

LLD Liquid level detection

n/a Not applicable

QC Quality control

REF Reference solution for ISE unit

ROM Read only memory

SD Standard deviation

SRAM Static random access memory

TRL Test range low (lower limit of measuring range)

Cedex Bio System

Roche Diagnostics

8 Operator’s Manual · Version 3.1

Units Abbreviation Description

°C degree centigrade

μLmicroliter

μm micrometer

A ampère

cm centimeter

hhour

Hz hertz

LB pound (weight)

in inch

kg kilogram

kVA kilo volt-ampere

L liter

m meter

MB megabytes

min minute

mL milliliter

mm millimeter

nm nanometer

ssecond

Vvolt

VA volt-ampère

V AC volt alternating current

V DC volt direct current

Wwatt

1 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

2 Introduction to the instrument . . . . . . . . . . . . . . . . . . . . . . . . . A-15

3 Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-37

4 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-67

System Description A

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